This course focuses on the technical writing skills required to prepare and review pharmaceutical documents such as Standard Operating Procedures (SOPs), change control documents, deviation reports, and other Good Manufacturing Practices (GMP) documents. Students will learn the principles of technical writing, including formatting, style, tone, and language. The course will cover the regulatory requirements and guidelines for technical writing in the pharmaceutical industry, including cGMP, FDA and EMA guidelines.
Through hands-on exercises and case studies, students will develop their technical writing skills and learn how to effectively communicate complex technical information to a wide range of stakeholders, including manufacturing personnel, quality control specialists, and regulatory authorities. Students will learn how to write clear and concise SOPs, change control documents, deviation reports, and other GMP documents. The course will cover best practices for writing, reviewing, and revising documents, and students will gain an understanding of document control processes and version control.
Upon completion of the course, graduates will have the technical writing skills and knowledge needed to prepare and review high-quality pharmaceutical documents in compliance with regulatory requirements and guidelines. This course is suitable for individuals working in the pharmaceutical, biotech, or medical device industries, including technical writers, quality assurance professionals, and regulatory affairs specialists.